System and method for managing a use of a substance delivery device and a substance delivery device

ABSTRACT

A system and method are for managing a use of a substance delivery device, and a delivery device delivers substances.

BACKGROUND OF THE INVENTION

Substance delivery devices (e.g., e-cigarettes, inhalers, vaporizes, etc.) are widely used today and the use thereof is rising continuously. Some such devices are used to replace smoking of cigarettes, in an attempt to prevent or reduce known health hazards that are associated with smoking. Furthermore, in order to reduce or prevent secondhand smoking and the unpleasantness and health risks associated therewith, restrictions on smoking in private and public places have become more and more prevalent.

Today, use of fluid delivery device in some places is a nuisance. Moreover, use of such devices by children and teens is on the rise, potentially causing early age addiction to delivered substances (e.g., nicotine) as well as potential health risks. Therefore, attempts have been made to prevent or reduce use of fluid delivery device by children and teens, as well as to prevent use of such fluid delivery device in miscellaneous locations (e.g., public places, etc.).

SUMMARY OF THE INVENTION

Some embodiments can provide a system for managing a use of a substance delivery device in a managing zone, the system can include: at least one system transmitter positioned to transmit a system signal into the managing zone; at least one system receiver positioned to receive a device signal from within the managing zone; and at least one system control unit configured to control the at least one system transmitter to transmit the system signal based on receiving the device signal by the at least one system receiver.

In some embodiments, the system can include a substance delivery device, the substance delivery device having a device transmitter configured to transmit the device signal.

In some embodiments, the system signal includes at least one of a soundwave and electromagnetic wave.

In some embodiments, the system signal is not detectible by humans.

In some embodiments, the device signal includes at least one of a soundwave and electromagnetic wave.

In some embodiments, the managing zone is at least partially enclosed by walls.

Some embodiments can provide a system for managing a use of a substance delivery device in a managing zone, the system can include: at least one system receiver capable of receiving a device signal transmittable by a substance delivery device; at least one system transmitter; and at least one system control unit configured to control the at least one system transmitter to transmit, into the managing zone, at least one of: a baseline signal; and a managing signal, being transmitted subject to receipt of at least a portion of the device signal by the at least one system receiver.

In some embodiments, the at least one system control unit is configured to control the at least one system transmitter to transmit the baseline signal at least when no device signal is received by the at least one system receiver.

In some embodiments, the at least one system control unit is configured to: encode at least one of: the managing signal and the baseline signal to include at least one managing command using a predetermined set of signal encoding parameters, wherein the at least one managing command defines a function to be performed by the substance delivery device upon receipt of the at least one of: the managing signal and the baseline signal.

In some embodiments, the function includes a function selected from the group consisting of:

blocking the substance delivery device for operation, terminating the operation of the substance delivery device, modifying the operation of the substance delivery device, issuing a notification, and any combination thereof

In some embodiments, at least one of the baseline signal and the managing signal includes a jamming signal is configured to at least one of: interfere directly with an oral authentication by the substance delivery device; and at least partly overlap with waves used by the substance delivery device for the oral authentication.

In some embodiments, the at least one system control unit is configured to: control the at least one system transmitter to transmit a release signal; and encode the release signal to include a release managing command using a predetermined set of signal encoding parameters; wherein the release managing command causes the substance delivery device to stop performing the function upon receipt of the release signal.

In some embodiments, the at least one system control unit is: associated with a database for registering permitted substance delivery devices; and configured not to interfere with the operation of the permitted substance delivery devices.

In some embodiments, the at least one system control unit is configured to: retrieve device-related information from the device signal based on a predetermined set of device-related information encoding parameters; and encode or select the managing signal based on the device-related information.

In some embodiments, the at least one system control unit is configured to determine a location of the substance delivery device within the managing zone based on at least one of: the device signal and a known location of at least one system receiver that has received the device signal.

In some embodiments, the at least one system control unit is configured to: define at least two managing sub-zones within the managing zone; and control the at least one system transmitter to transmit at least one of: the baseline signal within each of the at least two managing sub-zones, and at least two managing signals, wherein at least one of the managing signals transmitted in a first managing sub-zone of the at least two managing sub-zones is not transmitted in a second managing sub-zone of the at least two managing sub-zones.

In some embodiments, the at least one system control unit is configured to: define at least two managing sub-zones within the managing zone; and control the at least one system transmitter to transmit at least one of: the baseline signal within each of the at least two managing sub-zones, and at least two release signals, wherein at least one of the release signals transmitted in a first managing sub-zone of the at least two managing sub-zones is not transmitted in a second managing sub-zone of the at least two managing sub-zones.

Some embodiments can provide a method of managing a use of a substance delivery device in a managing zone, the method can include: receiving, by at least one receiver, from within the managing zone, a device signal transmittable by the substance delivery device; and transmitting, by at least one transmitter, into the managing zone, a managing signal upon receipt of at least a portion of the device signal; wherein the managing signal is receivable by the substance delivery device when the substance delivery device is within the managing zone and is capable of causing the substance delivery device to perform a function.

In some embodiments, the method can include transmitting, by the at least one transmitter, a baseline signal, the baseline signal being receivable by the substance delivery device when the substance delivery device is within the managing zone.

In some embodiments, the method can include transmitting, by the at least one transmitter, the baseline signal at least when no device signal is received by the at least one receiver.

In some embodiments, the method can include encoding, by at least one control unit, at least one of: the managing signal and the baseline signal to include at least one managing command using a predetermined set of signal encoding parameters, wherein the at least one managing command defines the function.

In some embodiments, the function includes a function selected from the group consisting of at least one of: blocking the substance delivery device for operation, terminating the operation of the substance delivery device, modifying the operation of the substance delivery device, issuing a notification and any combination thereof

In some embodiments, at least one of: the baseline signal and the managing signal, includes a jamming signal, the jamming signal is configured to at least one of: interfere directly with an oral authentication by the substance delivery device; and at least partially overlap with waves used by the substance delivery device for the oral authentication.

In some embodiments, the method can include transmitting, by the at least one transmitter, a release signal; and encoding, by at least one control unit, the release signal to include a release managing command using a predetermined set of signal encoding parameters; wherein the release managing command causes the substance delivery device to stop performing the function upon receipt of the release signal.

In some embodiments, the method can include: determining, by at least one control unit, whether the substance delivery device is a permitted substance delivery device by retrieving information from a database of registered permitted substance delivery devices; and preventing from the by at least one control unit to interfere with operation of the permitted substance delivery devices.

In some embodiments, the method can include retrieving, by at least one control unit, device-related information from the device signal based on a predetermined set of device-related information encoding parameters, and encoding, by the at least one control unit, the managing signal based on the device-related information.

In some embodiments, the method can include determining, by at least one control unit, a location of the substance delivery device within the managing zone based on at least one of the device signal and a known location of at least one receiver that has received the device signal.

In some embodiments, the method can include defining, by at least one control unit, at least two managing sub-zones within the managing zone; and controlling the at least one transmitter to transmit at least one of: the baseline signal within each of the two managing sub-zones, and at least two managing signals, wherein at least one of the managing signals transmitted in a first managing sub-zone of the at least two managing sub-zones is not transmitted in a second managing sub-zone of the at least two managing sub-zones.

In some embodiments, the method can include defining, by at least one control unit, at least two managing sub-zones within the managing zone; and controlling the at least one transmitter to transmit at least one of: the baseline signal within each of the at least two managing sub-zones, and at least two release signals, wherein at least one of the release signals transmitted in a first managing sub-zone of the at least two managing sub-zones is not transmitted in a second managing sub-zone of the at least two managing sub-zones.

Some embodiments can include a substance delivery device, the substance delivery device can include: a reservoir region configured to house a reservoir of a substance within the substance delivery device; a device receiver for receiving a system signal transmittable by a managing system in a managing zone; and a device controller for performing a function upon receipt of the system signal by the device receiver.

In some embodiments, the system signal includes at least one of a managing signal and a baseline signal.

In some embodiments, the function includes a function selected from the group consisting of at least one of: blocking the substance delivery device for operation, terminating the operation of the substance delivery device, modifying the operation of the substance delivery device, issuing a notification and any combination thereof

In some embodiments, the substance delivery device can include a device transmitter, wherein the device controller is configured to control the device transmitter to transmit a device signal.

In some embodiments, the device controller is configured to encode the device signal to include device-related information using a predetermined set of device-related information encoding parameters.

In some embodiments, the device controller is configured to control the device transmitter to transmit the device signal upon at least one of commencement of operation of the substance delivery device, commencement of user authentication by the device, and upon commencement of a substance delivery.

In some embodiments, the device controller is configured to determine the function to be performed based on the system signal received by the device receiver and based on a predetermined set of encoding rules and cause the substance delivery device to perform the function.

In some embodiments, the device controller is configured to at least one of: cause the substance delivery device to perform the function for a predetermined time interval subsequent to receipt of the system signal; and cause the substance delivery device to perform the function until a release signal is received by the device receiver.

In some embodiments, the function includes preventing the substance delivery device from delivering a substance and wherein preventing the substance delivery device from delivering a substance includes preventing an authentication of an individual.

In some embodiments, the substance delivery device can include an oral authentication unit configured to transmit waves into or in a vicinity of a mouth of a user and receive at least a portion of waves reflected from the user, and wherein the device controller is configured to perform an oral authentication of the user based on the reflected waves and to deliver the substance at least partially based on the result of the authentication.

In some embodiments, the substance delivery device is at least one of a pulmonary delivery device, an inhaler device, an e-cigarette device, a vaporizer device, a nasal applicator device, a syringe device, a medical device, a non-medical device and any combination thereof

Some embodiments can provide system for managing a use of a substance delivery device in a managing zone, the system can include: at least one system transmitter positioned to transmit a system signal into the managing zone; and a substance delivery device that can include: a device receiver capable of receiving the system signal; and a device controller configured to control a function of the substance delivery device based on receipt of the system signal by the device receiver.

In some embodiments, the function includes delivery of a substance by the substance delivery device.

In some embodiments, the device controller is configured to prevent the delivery of the substance by the substance delivery device in response to receipt of the system signal.

In some embodiments, the device controller is configured to at least one of: control the function of the substance delivery device based on receipt of the system signal by the device receiver for a predefined duration after receipt of the system signal; and control the function of the substance delivery device based on receipt of the system signal by the device receiver until a release signal is received by the device receiver.

In some embodiments, the substance delivery device includes a device transmitter and wherein the function includes transmitting a device signal by the device transmitter.

In some embodiments, at least one system receiver capable of receiving the device signal; and at least one system control unit configured to control the at least one system transmitter to transmit a managing signal based on receiving the device signal by the at least one system receiver.

In some embodiments, the function includes an authentication of an individual by the substance delivery device.

In some embodiments, the system signal is configured to at least one of: interfere with a wave-based oral authentication of the individual; and partially overlap with waves used by the substance delivery device for oral authentication.

In some embodiments, the substance delivery device is at least one of a pulmonary delivery device, an inhaler device, an e-cigarette device, a vaporizer device, a nasal applicator device, a syringe device, a medical device, a non-medical device and any combination thereof

Some embodiments can provide a system for preventing a use of a substance delivery device in a managing zone, the system can include: at least one system transmitter capable of transmitting a system signal, wherein: the signal is receivable by a substance delivery devices when present within a managing zone, wherein the substance delivery device includes an oral authentication unit configured to transmit waves into or in a vicinity of a mouth of a user and receive at least a portion of waves reflected from the user, and wherein a controller of the substance delivery device is configured to perform an oral authentication of the user based on the reflected waves and to deliver the substance at least partially based on the result of the authentication; and the system signal at least partially overlaps with waves used by the substance delivery device for user authentication and configured to interfere with the oral authentication.

These, additional, and/or other aspects and/or advantages of the present invention are set forth in the detailed description which follows; possibly inferable from the detailed description; and/or learnable by practice of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of embodiments of the invention and to show how the same can be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings in which like numerals designate corresponding elements or sections throughout.

In the accompanying drawings:

FIG. 1A is a schematic block diagram of a system for managing a use of a substance delivery device in a managing zone, according to some embodiments of invention;

FIG. 1B is a schematic illustration of one example of a system for managing a use of a substance delivery device in a managing zone, according to some embodiments of invention;

FIG. 2 is a schematic illustration of a substance delivery device, according to some embodiments of invention;

FIG. 3 is a flowchart of a method of managing a use of a substance delivery device in a managing zone, according to some embodiments;

FIG. 4 is a block diagram of a substance delivery device for delivery of a substance to an individual, according to some embodiments;

FIG. 5A and 5B are schematic diagrams of a substance delivery device, according to some embodiments of the invention

FIG. 5C are graphs showing an example of a received wave without a cover on the wave sensor, according to some embodiments of invention;

FIG. 5D are graphs showing an example of the same received waves with a cover on the wave sensor, according to some embodiments of invention;

FIG. 6 is a flowchart of a method of authenticating an individual for delivery of a substance to the individual, according to some embodiments of invention;

FIG. 7A and FIG. 7B are T-distributed Stochastic Neighbor Embedding (t-SNE) graph, and an enlargement of a portion thereof, visualizing a possible distinction between received waves from eight different individuals, according to some embodiments of an authentication method;

FIG. 7C and FIG. 7D are graphs showing a reference wave used in determining the values of wave samples shown in graph of FIG. 7A, according to some embodiments of an authentication method; and

FIG. 8A and FIG. 8B are T-distributed Stochastic Neighbor Embedding (t-SNE) graph, and an enlargement of a portion thereof, visualizing a possible distinction between adults and children according to received waves, according to some embodiments of an authentication method.

It will be appreciated that, for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements can be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals can be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, various aspects of the present invention are described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the present invention. However, it will also be apparent to one skilled in the art that the present invention can be practiced without the specific details presented herein. Furthermore, well known features can have been omitted or simplified in order not to obscure the present invention. With specific reference to the drawings, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention can be embodied in practice.

Before at least one embodiment of the invention is explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is applicable to other embodiments that can be practiced or carried out in various ways as well as to combinations of the disclosed embodiments. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

Unless specifically stated otherwise, as apparent from the following discussions, it is appreciated that throughout the specification discussions utilizing terms such as “processing”, “computing”, “calculating”, “determining”, “enhancing” or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulates and/or transforms data represented as physical, such as electronic, quantities within the computing system's registers and/or memories into other data similarly represented as physical quantities within the computing system's memories, registers or other such information storage, transmission or display devices. Any of the disclosed modules or units can be at least partially implemented by a computer processor.

Reference is now made to FIG. 1A, which is a schematic block diagram of a system 100 for managing a use of a substance delivery device 90 in a managing zone 80, according to some embodiments. Substance delivery device 90 can be a pulmonary delivery device. Substance delivery device 90 can be an e-cigarette, a vaporizer or an inhaler. Substance delivery device 90 may be a medical device, a non-medical device or a combination thereof. Substance delivery device 90 can be and electronic device.

According to some embodiments, system 100 includes one or more system transmitters 110, one or more system receivers 120 and a system control unit 130.

System transmitter(s) 110 can generate and/or transmit one or more baseline signals 112 within managing zone 80. In some embodiments, baseline signal 112 is undetectable by humans and animals (or domesticated animals). In various embodiments, baseline signal 112 includes a sound wave or is a sound wave. In some embodiments, the sound wave has a frequency above 200 kHz. In some embodiments, the sound wave has a frequency above 100 kHz. In some embodiments, the sound wave has a frequency above 80 kHz. In some embodiments, the sound wave has a frequency above 30 kHz. In various embodiments, baseline signal 112 is an electromagnetic wave or includes an electromagnetic wave.

Baseline signal(s) 112 can be received by substance delivery device 90 upon or after entry of substance delivery device 90 into the managing zone 80. Baseline signal(s) 112 can, for example, cause an initiation/activation of a communication channel between the system 100 and substance delivery device 90.

System control unit 130 can include one or more processors. In various embodiments, system control unit 130 controls system transmitter(s) 110 to continuously or periodically transmit baseline signal(s). For example, baseline signal(s) can be transmitted every 1 min, every 5 mins, etc. In some embodiments, baseline signal(s) 112 are transmitted continuously. In various embodiments, system control unit 130 controls system transmitter(s) 110 in response to receipt of a device signal 92 at system receiver(s) 120.

In some embodiments, system control unit 130 controls system transmitter(s) 110 to transmit (e.g., either continuously or periodically) one type of baseline signal 112 being detectable by all substance delivery devices 90 having a compatible signal receiver. In some embodiments, system control unit 130 controls system transmitter(s) 110 to transmit (e.g., either continuously or periodically) two or more different baseline signals 112, each of which being detectable by a distinct signal receiver. Optionally, distinct types of substance delivery devices 90 (e.g., different substance, different purpose and/or different manufacturer) can detect distinct baseline signals, for example according to the type of receiver incorporated therein and/or by virtue of different controller configuration. For example, an e-cigarette and a medical inhaler can operate under different control regimes in the same managing zone 80.

System receiver(s) 120 can receive one or more device signals 92 transmittable by substance delivery device 90. For example, when substance delivery device 90 enters managing zone 80, and/or when substance delivery device 90 is within managing zone 80, substance delivery device 90 can receive baseline signal(s) 112 and/or in response, transmit device signal(s) 92. Receipt of device signal(s) 92 by system receiver(s) 120 can be indicative of, for example, a presence of substance delivery device 90 in managing zone 80. In some embodiments, the system control unit 130 can detect that substance delivery device 90 has entered and/or is present within the managing zone 80 upon receipt of the device signal(s) 92 by the system receiver(s) 120.

Device signal(s) 92 transmitted substance delivery device 90 can, for example, encode device-related information using a predetermined set of device-related information encoding parameters. In some embodiments, system control unit 130 retrieves the device-related information based on device signal(s) 92 received by system receiver(s) 120.

For example, the device-related information can include a type of substance delivery device 90 (e.g., nicotine or tobacco e-cigarette, controlled substance delivery device, cannabis or cannabinoid containing device, medical substance delivery device, non-medical substance delivery device, combined medical and non-medical substance delivery device, etc.). In some embodiments, the device-related information can include a unique identifier (e.g. serial number) of the substance delivery device 90. In some embodiments, the device-related information includes details of a user of substance delivery device 90. In some embodiments, the device-related information includes information concerning a substance being used by substance delivery device 90 (e.g., a type of the substance, batch information, etc.). In some embodiments, the device-related information includes data indicative of biometric authentication information (or a portion thereof) of a user of the substance delivery device 90.

In some embodiments, system control unit 130 controls system transmitter(s) 110 to transmit one or more managing signals 114 upon receipt of device signal(s) 92 by system receiver(s) 120. Managing signal(s) 114 can be detectable by substance delivery device 90 when substance delivery device 90 is within managing zone 80. In some embodiments, the managing signal is undetectable by humans and animals (or domesticated animals). In various embodiments, the managing signal includes a sound wave or is a sound wave. In some embodiments, the sound wave is at a frequency of above 200 kHz. In some embodiments, the sound wave is at a frequency of above 100 kHz. In some embodiments, the sound wave is at a frequency of above 80 kHz. In some embodiments, the sound wave is at a frequency of above 30 kHz. In various embodiments, the managing signal includes an electromagnetic wave or is an electromagnetic wave.

In some embodiments, managing signal(s) 114 causes substance delivery device 90 to perform one or more functions. For example, substance delivery device 90 can perform at least one of: block the substance delivery device for operation, terminate the operation of the substance delivery device, modify the operation of the substance delivery device, and/or issue a notification, in response to receipt of managing signal(s) 114. In various embodiments, system control unit 130 controls system transmitter(s) 110 to continuously or periodically transmit managing signal(s) 114.

In some embodiments, system control unit 130 encodes managing signal(s) 114 to include one or more managing command(s). In some embodiments, system control unit 130 encodes one or more managing command(s) based on a predetermined set of encoding rules. For example, each managing command can be encoded using a predetermined set of signal encoding parameters (e.g., signal duration, signal periodicity, signal wavelength, signal bandwidth, signal frequency, signal relative intensity, signal pattern over time and/or any wave properties, etc.). The predetermined set of signal encoding parameters can be unique for the particular managing command and/or the particular substance delivery device. The parameters can be selected in real time for example as is known in encryption. Substance delivery device 90 can retrieve the managing command(s) from managing signal(s) 114 based on the predetermined set of encoding rules and perform one or more functions defined by the managing command(s).

In some embodiments, system control unit 130 encodes managing signal(s) 114 based on the device-related information of substance delivery device 90 (e.g., received from substance delivery device 90 via device signal(s) 92). In this manner, system control unit 130 can generate managing signal(s) 114 capable of managing use of each particular substance delivery device or groups of substance delivery devices. For example, managing signal(s) 114 can be encoded to prevent authentication dependent operations of substance delivery device 90. In some embodiments, authentication includes obtaining a biometric property of the individual and authenticating the individual based on the obtained biometric property. Examples for biometric property include fingerprint, facial recognition and oral signature. In some embodiments, authentication is prevented by one or more of preventing the obtaining of the biometric property, preventing use of an obtained biometric property in authentication and preventing operation of an authentication dependent feature (e.g., one or more stages of dsubstance delivery) regardless of the result of authentication. In some embodiments, managing signal(s) 114 are encoded to restrict a delivery of a substance by substance delivery device 90 (e.g., restrict dosage, regimen, some but not all substances, restrict the operation to given time slots, etc.).

In some embodiments, the system control unit 130 encodes managing signal(s) 114 to temporally manage substance delivery device 90 for a predetermined time interval upon receipt of managing signal(s) 114. For example, the managing signal(s) 114 can be encoded to block substance delivery device(s) 90 for a predetermined time interval, after which substance delivery device(s) 90 can be released for normal operation independent from system 100.

In various embodiments, managing signal(s) 114 are jamming signal(s) for disrupting signal transmittal and/or detection by substance delivery devices in the managing zone 80. In some embodiments, the jamming managing signal(s) are selected based on a property of substance delivery device 90. The property of substance delivery device 90 can be derived from the received device signal(s) 92. In some embodiments, the jamming signals can prevent substance delivery device 90 from performing authentication of a user and/or otherwise from delivering a substance. In some embodiments, authentication of a user is essential for the delivery of a substance to the individual. For example, some substance delivery device can include an oral authentication unit, as is exemplified in further detail in FIGS. 2, 4, 5A and 5B). The oral authentication unit can, for example, transmit waves (e.g., acoustic waves or electromagnetic waves) into or in a vicinity of a mouth of a user, receive at least a portion of waves reflected from the user and perform an oral authentication of the user based at least partially on the reflected waves. The jamming signal(s) can, for example, interfere with the waves being transmitted by the oral authentication unit and thereby prevent the oral authentication of the user. In some embodiments, the jamming signal(s) can at least partly overlap with a wave pattern of the oral authentication unit used for the oral authentication. The jamming signal(s) can optionally be transmitted at a frequency that at least partially overlaps with at least one frequency used for authentication and have a power that can be detected by the authentication system. In some embodiments, the jamming signal(s) can cause noise in the authentication process that can prevent the authentication from completion. The jamming signal can be transmitted with a frequency and power that is recognized or conflated by the substance delivery device as a baseline signal or management signal. In some embodiments, a property of the jamming signal is selected so as to ensure interference. For example, the power or amplitude of a wave can be selected to be sufficient to be received by the device receiver when in a pocket or outside it. In some embodiments, data encoded in the device signal affect a property of the transmitted jamming signal (e.g., frequency selection and/or amplitude). Optionally, the system controller is configured to control at least one system transmitter to transmit a system signal having varying properties until a device device signal is received to indicate that jamming has occurred. Optionally, the device controller is configured to transmit a device signal indicating that jamming has occurred upon failed authentication or upon a chain of failed authentication attempts.

In some embodiments, system control unit 130 provides exclusion to substance delivery device(s) 90 (e.g., specific and/or based on device type) so as not to interfere with the use thereof. The indication of such exclusion can be registered for example in a database 140. In some embodiments, the exclusion is based on device-related information received from substance delivery device 90 via device signal(s) 92. For example, system control unit 130 can permit devices identified as medical inhalers to be used within managing zone 80, optionally with a restriction that can be relayed by a notification issued by system control unit 130. This may be performed by, for example, the processor(s) of system control unit 130. In some embodiments, system control unit 130 is implemented at a school. In some of these embodiments, the system control unit 130 permits adult employees to use nicotine e-cigarettes but not other individuals and/or can wholly prevent cannabis inhalers. In some embodiments, at a hospital, licensed medical cannabis delivery devices can be approved for use at any location within the hospital, while other substance delivery devices (e.g., visitors' or personnel's non-medical cannabis and/or tobacco devices) can be blocked.

A list of the registered substance delivery device(s) or types of devices can be stored in, for example, a system database 140. In various embodiments, a list of permitted users and/or a list of their permitted devices can be stored in, for example, a system database 140. In some embodiments, the system requires both device type and data indicative of a permitted user authentication, in order to allow an exclusion. In some embodiments, the system control unit 130 encodes a non-blocking managing command in managing signal(s) 114 so as not to block the registered substance delivery device. In some embodiments, system control unit 130 encodes a block override managing command in managing signal(s) 114 so as to un-block the registered substance delivery device (if, for example, all devices are initially blocked by default).

In some embodiments, system control unit 130 controls the system transmitter(s) 110 to transmit both baseline signal(s) 112 and managing signal(s) 114. For example, system transmitter(s) 110 can simultaneously and/or interchangeably transmit baseline signal(s) 112 and managing signal(s) 114. In some embodiments, system 100 includes different transmitter(s) 110 for transmitting baseline signal(s) 112 and managing signal(s) 114. In this manner, for example, system 100 can concomitantly detect and/or open communication channels with substance delivery device(s) 90 that has just entered managing zone 80 via baseline signal(s) 112, and manage substance delivery device(s) 90 that are already in managing zone 80 via managing signal(s) 114. In various embodiments, system control unit 130 controls system transmitter(s) 110 to transmit only baseline signal(s) 112 or only management signal(s) 114.

In some embodiments, system control unit 130 determines a location of substance delivery device 90 within managing zone 80 based on device signal(s) 92 received by system receiver(s) 120. For example, device signal(s) 92 can include a location information of substance delivery device 90 (e.g., the location can be part of the device-related information). In some embodiments, location(s) of system receiver(s) 120 within managing zone 80 are stored in database 140 of system 100. System control unit 130 can identify receiver(s) 120 that received device signal(s) 92 and retrieve the location of the respective receiver(s) from database 140. Optionally, a plurality of receiver(s) 120 receive device signal(s) 92, and the system can retrieve the location of the device based at least partially on the relative intensity of the received device signal(s) 92 at each of receiver(s) 120, and the respective location of each receiver.

In some embodiments, system 100 includes a system communication unit 150. System communication unit 150 can be capable of issuing one or more notifications. System communication unit 150 can issue notification(s) to substance delivery device 90 or to a third party. The third party can, for example, include at least one of: zone/site manager, e.g., school manager, related medical staff members, caregiver/parent, law enforcement agent, device source companies (for example manufacturers, distributers, etc.), pharmaceutical companies and/or personal digital assistance devices (e.g., smartphones) associated with particular substance delivery devices and/or particular users thereof, etc.

For example, system control unit 130 can control system communication unit 150 to issue a notification concerning a presence of substance delivery device 90 within managing zone 80 upon receipt of device signal(s) 92 by system receiver(s) 120 to a system and/or zone manager (e.g. for display on a monitor) and/or to the substance delivery device 90 and/or a computer or other device associated with the substance delivery device. This notification can, for example, include the location of substance delivery device(s) 90 and/or other device-related information. This notification can be issued, for example, to a manager of managing zone 80. In some embodiments, system control unit 130 controls system communication unit 150 to issue a notification concerning factory recall, optionally based on device-related information (e.g., device production batch and/or the substance's production batch) to substance delivery device 90. Optionally, a factory recall is issued and received by all substance delivery devices 90 in managing zone 80, wherein the factory recall notification includes recall details (e g manufacturer, batch number, serial number or the substance delivery device and/or a reservoir in use with the substance delivery device, etc.) sufficient for a device controller to deduce whether the notification is intended for the respective substance delivery device.

In some embodiments, system control unit 130 can control system communication unit 150 to issue a notification relating to use of the substance delivery device (e.g., information concerning new recommended substance use regimens, health warnings like smoking is harmful warnings, etc.).

In some embodiments, the borders of managing zone 80 are defined by a reception area of baseline signal(s) 112 and/or managing signal(s) 114 being transmitted by system transmitter(s) 110.

In some embodiments, managing zone 80 is enclosed within a wall enclosed structure, such as a building or a room within a building.

Reference is now made to FIG. 1B, which is a schematic illustration of a system 101 for managing a use of a substance delivery device 91 in a managing zone 81, according to some embodiments.

System 101 can have some features similar to system 100 described above with respect to FIG. 1A. In some embodiments, system 101 includes one more system transmitters 111, one or more system receivers 121, a system control unit 131, a system database 141 and a system communication unit 151. System transmitter(s) 111, system receiver(s) 121, system control unit 131, system database 141 and system communication unit 151 can have some features similar to system transmitter(s) 110, system receiver(s) 120, system control unit 130, system database 140 and system communication unit 150, respectively, as described above with respect to FIG. 1A.

In some embodiments, system control unit 131 defines at least one of: one or more managing sub-zones and one or more release sub-zones in managing zone 81. In various embodiments, system control unit 131 controls one or more of system transmitter(s) 111 (e.g., transmitters 111 a-111 d shown in FIG. 1B) to transmit baseline signal(s) 113 and/or managing signal(s) 115 (e.g., managing signals 115 a-c shown in FIG. 1B) within the one or more managing sub-zones. In some embodiments, the system control unit 131 controls one or more of system transmitter(s) 111 (e.g., transmitters 111 a-111 d) to transmit one or more release signals 116 within the release sub-zones. System control unit 131 can encode release signal(s) 116 to, for example, include a release managing command so as substance delivery device(s) 91 that receive release signal(s) 116 operate unaffected by system 101. In various embodiments, system control unit 130 controls system transmitter(s) 111 a-d in response to receipt of a device signal 93 at system receiver(s) 121.

In various embodiments, borders of managing zone 81, managing sub-zones (e.g., managing sub-zones 81 a-c shown in FIG. 1B), release sub-zones (e.g., release subzone 81 d shown in FIG. 1B) are defined by a reception area of baseline signal(s) 113, managing signal(s) 115 and release signal(s) 116, respectively, being transmitted by system transmitter(s) 111. In some embodiments, any of managing zone 81, managing sub-zones (e.g., managing sub-zones 81 a-c shown in FIG. 1B), and release sub-zones (e.g., release subzone 81 d shown in FIG. 1B) is enclosed within a wall enclosed structure, such as a building or a room within a building.

For example, system control unit 131 can define a first managing sub-zone 81 a , a second managing sub-zone 81 b, and a third managing sub-zone 81 c in managing zone 81, in which a first system transmitter 111 a, a second system transmitter 111 b and a third system transmitter 111 c, respectively, can be controlled to transmit first managing signal(s) 115 a, second managing signal(s) 115 b and third managing signal(s) 115 c , respectively, as shown in FIG. 1B. In the example shown in FIG. 1B, system control unit 131 can define a release sub-zone 81 d in which a fourth system transmitter 111 d and a fifth system transmitter 111e can be controlled to transmit release signal(s) 116. It is noted that illustration shown in FIG. 1B is meant to be an example configuration only and that any number of system transmitter(s) 111 a-d, system receiver(s) 121 and relative locations thereof can be used. In some embodiments one or more of baseline signal(s) 113, managing signal(s) 115 a-c, and release signals 116 are undetectable by humans and animals (or domesticated animals). In various embodiments, one or more of these signals includes a sound wave or is a sound wave. In some embodiments, the sound wave is at a frequency of above 200 kHz. In some embodiments, the sound wave is at a frequency of above 100 kHz. In some embodiments, the sound wave is at a frequency of above 80 kHz. In some embodiments, the sound wave is at a frequency of above 30 kHz. In various embodiments, one or more of these signals includes an electromagnetic wave or is an electromagnetic wave.

In some embodiments, system control unit 131 encodes different managing commands in different managing signal(s) 115 being transmitted in different managing sub-zone of managing zone 81. In the example of FIG. 1B, first managing signal(s) 115 a being transmitted in first managing sub-zone 81 a encodes managing command(s) that can allow operation of a particular type of substance delivery devices only (e.g., medical substance delivery devices) and blocks operation of other substance delivery device(s). Second managing signal(s) 115 b being transmitted in second managing sub-zone 81 b encode managing command(s) that can allow operation of registered substance delivery devices only and block operation of other substance delivery devices. Third managing signal(s) 115 c being transmitted in third managing sub-zone 81 c encode managing command(s) that block operation of all substance delivery devices. Optionally, such signals include jamming signals.

In a specific example, managing zone 81 is a school or workplace and managing sub-zones 81 a and 81 b, for example, are designated smoking areas (e.g. a portion of a company, teachers' lounge, personal offices, etc.). In such example, baseline signal(s) 113 and/or managing signal(s) 115 c prevent use of fluid delivery devices within managing zone 81e. In managing sub-zones 81 a and 81b smoking is permitted and managing signal(s) 115 b and 115 a can serve as releasing signals. In some embodiments, smoking in one or more of managing sub-zones 81 a and 81 b is permitted only to specific identified individuals (e.g., teachers and other adult school employees) based on information transmitted by the substance delivery device 91. In some embodiments, release sub-zone 81 d is a region in the periphery of the school/office, possibly outside the fence (e.g., in proximity to gates in the fence) in which release signal(s) 116 is transmitted, such that substance delivery devices 91 leaving the managing zone (school, for example) become un-blocked.

In some embodiments, the system control unit (e.g., system control unit 130, 131 described above with respect to FIGS. 1A, 1B, respectively) controls system transmitter(s) (e.g., system transmitter(s) 110, 111 described above with respect to FIGS. 1A, 1B, respectively) to generate signals based on a predetermined set of signal type rules. The signals can, for example, be baseline signal(s) 112, 113, managing signal(s) 114, 115, described above with respect to FIGS. 1A, 1B, respectively, and release signal(s) 116 described above with respect to FIG. 1B. For example, different signals can differ from each other in at least one of signal parameters. The signal parameter(s) can, for example, include signal duration, signal periodicity, signal wavelength, signal bandwidth, signal frequency, signal relative intensity, signal pattern over time and/or any wave properties, etc.

In some embodiments, the system control unit controls system transmitter(s) to generate signals that have a predetermined signal complexity level. For example, the signals can be generated according to a predetermined identifiable set of parameters (e.g., signal duration, signal periodicity, signal wavelength, signal bandwidth, signal frequency, signal relative intensity, signal pattern over time and/or any wave properties, etc.). The signal complexity level can be set to reduce a probability that an arbitrary signal is considered by substance delivery devices (e.g., substance delivery devices 90, 91 described above with respect to FIGS. 1A, 1B, respectively) as one of the baseline signal(s), managing signal(s) and/or release signal(s). The signal complexity level can be set to reduce a probability of interference between different signals exchanged between the substance delivery device and the system. The signal complexity level can be set to reduce a probability of interference between signals exchanged between different substance delivery devices and the system. In some embodiments, the system control unit encrypts at least one of the signals being transmitter by the system transmitter(s). The encryption can ensure that the communication is authorized, and that the communication is not easily duplicated.

In various embodiments, the baseline signal(s) (e.g., baseline signal(s) 112, 113 described above with respect to FIGS. 1A, 1B, respectively) the managing signal(s) (e.g., managing signal(s) 114, 115 described above with respect to FIGS. 1A, 1B, respectively) and release signal(s) 116 are acoustic signals or electromagnetic signals.

It is noted that although single substance delivery device 90, 91 is shown in FIGS. 1A and 1B, respectively, it is to be understood that systems 100, 101 can each be capable of simultaneously managing use of multiple substance delivery devices 90, 91 within the respective managing zone 80, 81.

Reference is now made to FIG. 2, which is a schematic illustration of a substance delivery device 200, according to some embodiments.

Substance delivery device 200 communicates with a managing system 290. For example, managing system 290 is similar to system 100 and/or 101 for managing use of a substance delivery device described above with respect to FIGS. 1A and 1B.

According to some embodiments, substance delivery device 200 includes a device receiver 210 and a device controller 220.

In some embodiments, device receiver 210 receives one or more managing system signals 291 transmitted by managing system 290. The device receiver 210 can receive one or more baseline signals 292, one or more managing signals 294 and/or one or more release signals 296 from managing system 290. For example, baseline signal(s) 292 can be similar to baseline signal(s) 112, managing signal(s) 294 can be similar to managing signal(s) 114 and release signal(s) 296 can be similar to release signal(s) 116 described above with respect to FIGS. 1A and 1B.

Device controller 220 can detect the receipt of managing system signal(s) 291 by device receiver 210. In some embodiments, device controller 220 determines a type of managing system signal(s) 291 received by device receiver 210 based the predetermined set of signal type rules (e.g., as described above with respect to FIGS. 1A and 1B). For example, device controller 220 can determine whether the received managing system signal(s) 291 is baseline signal(s) 292, managing signal(s) 294 or release signal(s) 296. In some embodiments, device controller 220 authenticates the received signal(s) to confirm that they are not arbitrary signals approximating system signals. Such authentication can be based on whether the received signal conforms to a predetermined set of signal type rules and/or by two-way communication between substance delivery device 200 and the managing system 290.

Receipt of, for example, baseline signal(s) 292 can indicate that substance delivery device 200 has entered into or is located in a managing zone (e.g., as described above with respect to FIGS. 1A and 1B).

In some embodiments, substance delivery device 200 includes a device transmitter 230 for transmitting one or more device signals 232. In some embodiments, device signal transmitter 230 serves as a wave generator for oral authentication. In some embodiments, device signal transmitter 230 is different than the wave generator. In some embodiments, device transmitter 230 is configured to transmit waves differing in one or more wave properties, including for example wave type, frequency, bandwidth and/or transmission power.

Device signal(s) 232 can be receivable by managing system 290. Device signal(s) 232 can be similar to, for example, device signal(s) 92 described above with respect to FIGS. 1A and 1B. For example, device controller 220 can control device transmitter 230 to transmit device signal(s) 232 upon receipt of baseline signal 292 from managing system 290 to thereby establish/open a communication channel with managing system 290. In various embodiments, device signal(s) 232 are acoustic signals or electromagnetic signals. In some embodiments, one or more of device signal(s) 232 are undetectable by humans and animals (or domesticated animals). In some embodiments, one or more of these signals includes or is a sound wave. In some embodiments, the sound wave is at a frequency of above 200 kHz. In some embodiments, the sound wave is at a frequency of above 100 kHz. In some embodiments, the sound wave is at a frequency of above 80 kHz. In some embodiments, the sound wave is at a frequency of above 30 kHz. In some embodiments, one or more of these signals includes or is an electromagnetic wave. In some embodiments, one or more device signals 232 are generated according to a predetermined identifiable set of parameters (e.g., signal duration, signal periodicity, signal wavelength, signal bandwidth, signal frequency, signal relative intensity, signal pattern over time and/or any wave properties, etc.).

In some embodiments, device controller 220 encodes a device-related information in device signal(s) 232. The device-related information can include, for example, a type of substance delivery device 200 (e.g., nicotine or tobacco e-cigarette, cannabis or cannabinoid inhaler, controlled substance delivery device, medical substance delivery device, non-medical substance delivery device, combined medical and non-medical substance delivery device, etc.). In some embodiments, the device-related information includes a serial number of the substance delivery device 200. In some embodiments, the device-related information includes details of a user of the substance delivery device 200. In some embodiments, the device-related information includes information concerning a substance that is being used by substance delivery device (e.g., a type of the substance, batch information, manufacturer details, etc.). In some embodiments, the device-related information includes biometric authentication information (or at least a portion thereof) of a user of the substance delivery device 200. In some embodiments, the device-related information includes a location of the substance delivery device 200. In some embodiments, the device controller 220 encodes the device-related information using a predetermined set of device-related information encoding parameters (e.g., in a similar manner as described above with respect to FIGS. 1A and 1B).

In some embodiments, device controller 220 causes device transmitter 230 to transmit device signal(s) 232 upon turning on of substance delivery device 200 and/or upon commencement of operation of substance delivery device 200 to deliver a substance. In various embodiments, device controller 220 causes device transmitter 230 to continuously or periodically transmit device signal(s) 232.

Upon receipt of device signal(s) 232, managing system 290 can transmit managing signal(s) 294. Device controller 220 can perform one or more functions in response to receipt of managing system signals 291 (e.g. managing signals 294) by device receiver 210. In various embodiments, device controller 220 blocks substance delivery device 200 for operation, terminates the operation of substance delivery device 200 and/or modifies the operation of substance delivery device 200 (e.g., change a treatment/use regimen, prevent the delivery of one substance but not another, and/or restricts the delivery of a substance to specific times and/or amounts, etc.) upon receipt of the managing system signals 291 by the device receiver 210.

Managing signal(s) 294 transmitted by the managing system 290 can encode managing command(s) that can define function(s) to be performed by the substance delivery device 200 upon receipt of managing signal(s) 294. Managing signal(s) 294 can be encoded using a predetermined set of encoding rules (e.g., as described above with respect to FIGS. 1A and 1B). In some embodiments, device controller 220 determines function(s) to be performed based on the managing signal(s) 294 received by device receiver 210 and based on the predetermined set of encoding rules and cause substance delivery device 200 to perform the function(s) thereof.

In some embodiments, device controller 220 performs the function(s) encoded in received managing signal(s) 294 for a predetermined time interval. For example, device controller 220 can block substance delivery device 200 for a predetermined time interval upon receipt of respective managing command In some embodiments, such time interval is 5 minutes or longer, 15 minutes or longer or even 30 minutes or longer. In some embodiments, after the predetermined time interval has lapsed, the device controller 220 controls the substance delivery device 200 to resume operation. In some embodiments, receipt of a blocking command after the predetermined time interval has lapsed causes device controller 220 to block substance delivery device 200 from operating for a predetermined time interval, which can be the same as the previous predetermined time interval, shorter or longer. The predetermined time intervals can be input by a user. In some embodiments, after substance delivery device 200 was blocked for a predetermined time interval, the device resumes operating and cannot be blocked again by managing signal(s) 294, optionally for a predefined period of time or until the substance delivery device 200 was used to deliver a substance at least once. The device controller 220 can unblock substance delivery device 200 before the predetermined time interval ended upon receipt of release signal(s) 296.

In some embodiments, the device controller 220 performs the function(s) defined the managing command(s) encoded in received managing signal(s) 294 indefinitely, until device receiver 210 receives release signal(s) 296. Receipt of release signal(s) 296 by device receiver 210 can indicate that the substance delivery device has left the managing zone of managing system 290 (e.g., as described above with respect to FIGS. 1A and 1B). In some embodiments, the device controller 220 unblocks substance delivery device 200 upon receipt of release signal(s) 296 for a predetermined duration, during which substance delivery device 200 does not respond to any system signal(s) 291 or to a subset such as baseline signal(s) 292, management signal(s) 294 or a subset thereof

In some embodiments, substance delivery device 200 can be a permitted substance delivery device. In these embodiments, the device controller 220 controls substance delivery device 200 to ignore the baseline signal(s) 292 and/or the managing signal(s) 294 if received by the device receiver 210 and/or to refrain from transmitting a device signal(s) 232. In some embodiments, rendering a substance delivery device 200 to be a permitted device requires prior approval by an authorized individual. The authorized individual can use an override access to the programming of device controller 220 and/or a database associated therewith. In some embodiments, a permitted zone is registered on the substance delivery device 200 associated database. In some embodiments, the device controller 220 accesses the device database before operating according to a received managing system signal 291. In some embodiments, a permitted substance delivery device 200 is a registered device in managing system 290.

In some embodiments, substance delivery device 200 includes and/or is associated with a device communication unit 240. Communication unit 240 can issue one or more notifications. For example, the device controller 220 can control the device communication unit 240 to issue different notification(s) upon receipt of different managing system signal(s) 291 by the device receiver 210.

In various embodiments, device controller 220 controls device communication unit 240 to issue the notification(s) to a user of substance delivery device and/or to a third party. The notification(s) can be digital or analog. For example, device controller 220 can control device communication unit 240 to send a message to a digital assistance device (e.g., smartphone) associated with substance delivery device 200.

In some embodiments, communication unit 240 includes one or more indicators 242 capable of generating one or more indications. For example, upon receipt of baseline signal(s) 292 by device receiver(s) 210, device controller 220 can control indicator(s) 242 to generate indication(s) that substance delivery device 200 has entered to or is present in the managing zone of managing system 290. The indication(s) can be visual (e.g., flashing light, red light, etc.), audio (e.g., alarm signal, a melody, a recorded message, etc.), tactile (e.g. vibration), etc.

In some embodiments, device controller 220 generates a log of device-related events. For example, device controller 220 can record timestamps of at least one of: entrance to the managing zone of managing system 290, identification of managing system 290, locations in the managing zone of managing system 290 in which the substance delivery device 200 was present and when, commencements of operations and/or attempts thereof, optionally with precise location of such operations and/or attempts. In various embodiments, device controller 220 can control device communication unit 240 to send the log to the user and/or the third party (e.g. via managing system 290 such as to the system manager and/or via device communication to any other third party) or to save the log in a device memory 250.

In some embodiments, substance delivery device 200 includes an oral authentication unit 260. Oral authentication unit 260 can, for example, transmit waves (e.g., acoustic and/or electromagnetic waves) into or in a vicinity of a mouth of a user and receive at least a portion of waves reflected from the user. Device controller 220 can perform an oral authentication of the user based on the reflected waves. Some of managing signal(s) 296 can be jamming signals (e.g., as described above with respect to FIGS. 1A and 1B). The jamming signal(s) can, for example, interfere with the waves being transmitted by oral authentication unit 260 and thereby prevent the oral authentication of the user. For example, the jamming signal(s) can at least partly overlap with a wave pattern of oral authentication unit 260 used for the oral authentication.

Substance delivery device 200 can be for example any one of a pulmonary delivery device (for example an inhaler device, an e-cigarette device, a vaporizer device), a nasal applicator device and a syringe device or a combination thereof. Substance delivery device 200 can be a medical device, a non-medical device or a combination thereof. For example, substance delivery device 200 can deliver nicotine, alone and/or concomitantly with other substances. Optionally, nicotine can be delivered directly from tobacco and/or from a liquid or other extract and/or synthetic source containing nicotine. In some embodiments, substance delivery device 200 can deliver at least one cannabinoid, alone and/or concomitantly with other substances. Optionally, the at least one cannabinoid can be delivered directly from cannabis and/or from a liquid or other extract and/or synthetic source containing the cannabinoid.

Reference is now made to FIG. 3, which is a flowchart of a method of managing a use of a substance delivery device in a managing zone, according to some embodiments.

The method can be implemented by a system for managing a use of a substance delivery device in a managing zone (e.g., system 100 described above with respect to FIGS. 1A and 1B), which can be configured to implement the method. It is noted that the method is not limited to the flowcharts illustrated in FIG. 3 and to the corresponding description. For example, in various embodiments, the method needs not move through each illustrated box or stage, or in exactly the same order as illustrated and described.

Some embodiments can include transmitting at least one baseline signal within a managing zone (302). For example, baseline signal(s) 112, 113 as described above with respect to FIGS. 1A, 1B, respectively.

Some embodiments can include receiving a device signal from a substance delivery device (304). For example, device signal(s) 92, 232 transmitted by substance delivery device 90, 200, as described above with respect to FIGS. 1A, 2, respectively.

Some embodiments can include determining a location of the substance delivery device within the managing zone (306). The location of the substance delivery device can be determined based one at least one of: the at least one device signal and a known location of the at least one receiver that has received the at least one device signal, for example, as described above with respect to FIGS. 1A and 1B.

Some embodiments can include issuing a notification (308). For example, the notification can be issued by a communication unit (e.g., communication units 150, 151 described above with respect to FIGS. 1A, 1B, respectively) upon receipt, or in response to receipt, of the device signal, e.g., as described above with respect to FIGS. 1A and 1B.

Some embodiments can include transmitting a managing signal within the managing zone (310). For example, managing signal(s) 114, 115 described above with respect to FIGS. 1A and 1B, respectively.

Various embodiments can include simultaneously or interchangeably transmitting the at least one baseline signal and the at least one managing signal within the managing. For example, as described above with respect to FIGS. 1A and 1B.

Some embodiments can include encoding the managing signal to include a managing command using a predetermined set of signal encoding parameters, the managing signal is capable of causing the substance delivery device to perform one or more functions defined by the at least one managing command upon receipt of the at least one managing signal. For example, as described above with respect to FIGS. 1A and 1B.

Some embodiments can include retrieving a device-related information (312). The device-related information may be retrieved based on the device signal received from the substance delivery device and based on a predetermined set of device-related information encoding parameters (312). For example, as described above with respect to FIGS. 1A and 1B.

Some embodiments can include transmitting the managing signal based on the device-related information (314). For example, the managing signal may be encoded based on the device-related information as described above with respect to FIGS. 1A and 1B.

Some embodiments can include transmitting a jamming signal capable of interfering with an oral authentication performed by an oral authentication unit of the substance delivery device and capable of preventing the oral authentication thereof. For example, as described above with respect to FIGS. 1A and 1B.

Some embodiments can include registering the substance delivery device so as not to interfere with a use thereof. For example, as described above with respect to FIG. 1A.

Some embodiments can include encoding the managing signal to cause the substance delivery device to perform the at least one function for a predetermined time interval upon receipt of the at least one managing signal. For example, as described above with respect to FIGS. 1A and 1B.

Some embodiments can include defining at least one managing sub-zone and at least one release sub-zone within the managing zone (316). For example, managing sub-zones 81 a-c and release sub-zone 81 d as described above with respect to FIG. 1B.

Various embodiments can include transmitting the baseline signal and/or the managing signal within the at least one managing sub-zones (318). For example, as described above with respect to FIGS. 1A and 1B.

Some embodiments can include transmitting a release signal within the at least one release zones (320). For example, at the release signal can be capable of causing the substance delivery device to terminate performing the at least one function upon receipt of the at least one release signal, as described above with respect to FIG. 1B.

Reference is now made to FIG. 4, which is a block diagram of a substance delivery device 400 for delivery of a substance to an individual, according to some embodiments.

The substance delivery device 400 includes a substance delivery portion 414, an authentication module 412, an opening 426, a wave generator 422 and a wave sensor 424. In some embodiments, the substance delivery device is a device that may deliver to an individual a fluid (e.g., a gas, such as air and/or a liquid), optionally via the individual's mouth. In some embodiments, the substance delivery device may deliver a fluid into an individual's lungs. The delivered fluid may serve as a carrier of a substance. In the case of pulmonary delivery, the gas (optionally air) can serve as a carrier for the substance. The substance may be inhaled in any form, including for example vapor, powder, and/or aerosol. Optionally, the devices may be electronically controlled. In some embodiments, the substance delivery device may be a medical device. Examples for substance delivery devices for pulmonary delivery may include e-cigarettes, vaping devices and inhalers, used for medical and/or non-medical purposes. In some embodiments, the substance delivery device may be a device though which an individual may inhale air solely for the operation of authentication module 412.

The substance delivery portion 414 includes a reservoir 418, an actuator 416, conduit 420 (e.g., dispensing duct) and a valve 423. The authentication module 412 includes a processor 434, memory 431, storage 432, communication module 430 and a display 428.

The reservoir 418 can be coupled to the actuator 416 and the opening 426 via a conduit 420 (e.g., a dispensing duct). The actuator 416 can be coupled to the valve 423 positioned within the conduit 420 or at any other position that can regulate flow of the fluid within the substance delivery device. The processor 434 can be coupled to the wave generator 422, the wave sensor 424, the memory 431, the storage 432, the communication module 430, and/or the display 428.

The wave generator 422 can be an air pressure wave generator (e.g., generating audio waves, ultrasound waves). The wave generator 422 can be a low frequency buzzer. The wave generator 422 can be a MEMS based component. The wave generator 422 can transmit sound waves or electromagnetic waves. The wave generator 422 can transmit a single pulse wave and/or a plurality of pulsed waves.

In some embodiments, the wave generator 422 may by a speaker. In some embodiments wave generator 422 is a or includes a passive structure positioned in a substance delivery device such that it produces noise as air flows through or next to it (e.g. plurality of flapping sheets or a fan). In some embodiment a passive wave generator is breath actuated.

In some embodiments, the wave generator 422 transmits electromagnetic waves having one or more frequencies of visible light, ultra-violet light, infra-red light, and radiofrequency. In some embodiments, other ranges of electromagnetic waves may also be applicable. In some embodiments, the wave generator 422 transmits sound waves. In some embodiments, the transmitted sound waves are in the ultrasound frequency range. In some embodiments, the transmitted waves are or include waves at a range of 20 kilohertz to 1 gigahertz. In some embodiments, the transmitted waves are or include waves at a range of 1 gigahertz to 3 gigahertz, or higher. In some embodiments, the transmitted sound waves are in the frequency range of human hearing, e.g., have a frequency between 20 hertz to 20 kilohertz. In some embodiments, transmitted soundwaves have a frequency below 500 Hz. In some embodiments, the sound waves have a frequency range that may be annoying for individuals below a threshold age but inaudible for older ones. For example, sound waves between 15-20 kilohertz are typically only heard by children. Thus, the device can transmit sound waves in this range to cause children to be unable and/or reluctant to use the substance delivery device 400. In some embodiments, the sound waves are inaudible to the human ear (e.g., to avoid causing mental or physical harm).

The wave sensor 424 can be a sound sensor (e.g., e.g., microphone, directional microphone array). The sensor 424 can be a piezoelectric microphone. The sensor 424 can be a MEMS based component. The sensor 424 can comprise a noise dumper, in order to reduce the recorded background noise and increase the portion of recorded data typical to the individual. The sensor 424 can comprise a transducer, operative to convert received waves into electrical signals. Alternatively (not shown) the sensor and the converter can be separate components, each of them may be either analog or digital.

The authentication module 412 (or processor 434) can be configured to communicate with a remote device (e.g., a network server, a cloud based server, etc., medical service provider, etc.), for example, to update an operating system, to obtain and/or update, authentication data relating to an authorized individual or individuals, a list with details of one or more authorized individuals, and/or administration scheme or schemes associated with the authorized individual or individuals.

Authentication module 412 may be distributed in more than one location. For example, the display 428 and/or storage 432 may be in a smartphone. In various embodiments, one or more elements of the authentication module 412 are housed on a computing device that is in wired or wireless communication with the substance delivery device 400.

The display 428 can display information relating to the use of substance delivery device 400 and/or to the individual/s, or to a care worker, or others. The memory 431 can store use information, authentication information, registration information or any combination thereof. In various embodiments, the substance delivery device 400 includes a plurality of wave generators and/or a plurality of sensors. In various embodiments, one or more wave generators and one or more sensors are in the same housing.

In some embodiments, the valve 423 is a pressure dependent flow valve such that the substance only flows through the valve during inhalation, for example, when a generated inhalation pressure exceeds a threshold. In some embodiments, the wave generator 422 transmits only partially or only as long as the valve 423 is closed. In various embodiments, the valve is electrical and/or mechanical.

In some embodiments, the substance delivery device 400 does not include the authentication module 412 and only includes a processor. In some embodiments, the substance delivery device 400 does not include the valve 423. In various embodiments, one or more of the elements of the authentication module 412 are excluded from the substance delivery device 400.

The components of the substance delivery device 400 as shown in FIG. 4 can be housed in a single housing or in multiple housings. In various embodiments, reservoir 418 can house one or more substances of one or more cannabis derived substances, cannabinoids, prescribed drugs, medicine, pharmaceuticals, nicotine, tobacco, any substance known for smoking or smoking alternative, substances to cause various flavors and/or scents, controlled substances and substances derived from cannabis, substances derived from tobacco, or any substance as is known in the art.

The substance delivery device 400 can be an electronic substance delivery device and/or be battery/solar powered.

In some embodiments, the substance delivery device 400 includes a notification module (e.g. an alarm). The notification module can be issue audio notification, a visual notification or both (one or more of which may include an alarm). The notification can be triggered if the individual is identified as being below an age threshold and/or is identified as not being an authorized individual. In some embodiments, the alarm is located on a remote device (e.g., a smartphone and/or other computer in communication with the authentication module).

During operation the authentication module 412 can instruct the wave generator 422 to transmit waves when the opening 426 (e.g., mouthpiece) is positioned towards a mouth 42 (e.g., lips, tissue surrounding the lips, and/or oral cavity) of an individual, and the wave generator can transmit waves 44 towards the individual. This can take place, for example, upon request (e.g., pressing on a button, inhaling through a substance delivery device, placing the mouthpiece in one's mouth, providing an activation authorization, for example via software or by inputting a code etc.) and/or upon use (first use and/or other uses). As shown in FIG. 4, the opening 426 is positioned within the oral cavity 40, however, the opening 426 can be positioned in any position that allows the waves generated by the wave generator to impinge upon the mouth 42.

At least a portion of the waves can reflect from the mouth 42 of the individual causing reflections 46 that are detected by the sensor 424. In some embodiments, at least a portion of the waves 44 are absorbed by the oral cavity 40. In some embodiments, a sensor (not shown) is positioned a location that allows the sensor to detect absorption of the waves by the oral cavity 40 and/or mouth 42.

In some embodiments at least one of wave generator 422 and sensor 424 is positioned in direct physical contact with the mouth during the wave transmittal. In some embodiments, at least one of wave generator 422 and sensor 424 is positioned between the lips and in direct physical contact with one or both of the lips. In some embodiments at least one of wave generator 422 and sensor 424 is positioned in direct physical contact with one or more teeth. In some embodiments at least one of wave generator 422 and sensor 424 is positioned in direct physical contact with one or more of the tongues, and/or inner part of the mouth. In some embodiments wave generator 422 and sensor 424 are positioned within the individual's oral cavity and are not in contact with any organs (e.g. lips, teeth, inner part of mouth, and/or tongue).

In some of the embodiments where at least one of wave generator 422 and sensor 424 is enclosed within an enclosure, at least one enclosure is positioned in direct physical contact with a part of the mouth during the wave transmittal. In some embodiments, at least one enclosure is positioned between the lips and in direct physical contact with one or both of the lips. In some embodiments at least one enclosure is positioned in direct physical contact with one or more teeth. In some embodiments at least one enclosure is positioned in direct physical contact with one or more of the tongues, and/or inner part of the mouth. In some embodiments wave all enclosures are positioned within the individual's oral cavity and are not in contact with any organs (e.g. lips, teeth, inner part of mouth, and/or tongue).

The wave sensor 424 can transmit the detected reflections to the processor 434. The processor 434 can process the detected reflections to determine whether the individual has permission to use the substance delivery device 400. If the individual has permission to use the substance delivery device 400, the individual can be authenticated.

Upon a successful authentication of the individual, the actuator 416 can activate the delivery of a substance housed within the reservoir 418 and/or control the valve 423 to a particular position, for example, fully open or partially open. The actuator 416 can activate a heating element (not shown) that heats the substance housed within the reservoir 418. The heated substance can flow through the conduit 420 into the oral cavity 40 of the individual. Optionally, the heated substance can undergo a chemical and/or structural change as a result of temperature its heating and/cooling. Optionally, the substance in the reservoir is liquid form and is optionally released by one or more of heating and pressure release. In some embodiments, the substance in the reservoir is in powder form and is released by heating and/or by extracting (or dispensing) powder away from the reservoir. In some embodiments the substance is in plant material is optionally released by heating or vaporization. In some embodiments, the substance is association with an air permeable structure (e.g., a pallet) from which it is extracted by allowing airflow through the structure and/or heating the structure. In some embodiments, the processor 434 controls the valve 423.

As is understood in the art, the substance delivery device 400 can have a reservoir that is empty and filled/refilled with one or more substances. Optionally, the reservoir is replaceable. For example, in some embodiments the reservoir is in the form of distinct substance carrying units each configured for one or several substance deliveries events (e.g., capsules, chips, cannister, etc.). Such reservoirs can be stored in a magazine for automatic replacing by the substance delivery device, or are replaceable manually.

In some embodiments, the substance delivery device 400 can require once or several (n number) authentications prior to delivering the substance, where n is an integer value. In various embodiments, during operation, the individual is repeatedly authenticated during use of the substance delivery device 400. The repeated authentication can occur by the processor 434 causing the wave generator 422 to transmit waves according to the desired authentication. The authentication can occur at a predefined time interval, after a triggering event, once or a predetermined number of times, with a periodicity over a predefined duration, or any combination thereof. The predefined duration and/or the periodicity can be input by an individual and/or be based on a type of the substance delivery device 400 and/or the type of substance to be delivered. For example, for a substance delivery device of a tobacco or nicotine e-cigarette the predefined interval can be 3-5 pulses per second. In various examples, for a substance delivery device of a pharmaceutical or controlled substance, the predefined interval can be 5-10 pulses per second. The predetermined time interval can be constant (e.g., every predetermined number of milliseconds, for example, in any of the following ranges: 5-50milliseconds, 50-200 milliseconds, 200-1000 milliseconds, every 1 second, every 5 seconds or every 10 seconds). In some embodiments, the predetermined time interval varies. For example, as substance delivery or inhalation (or exhalation) progresses, the periodicity may drop (e.g., from a periodicity of reiterating the authentication module every 30 milliseconds to reiterating it every 60 milliseconds, etc.). Optionally, for authentication that barely passes (e.g., a very young adult is identified) periodicity of the authentication process can increase (e.g., from a periodicity of reiterating the authentication module every 30 milliseconds to reiterating it every 10 milliseconds, etc.).

In some embodiments, the substance delivery device 400 can require several (n number) transmission to authenticate, where n is an integer value. For example, the substance delivery device 400 can require that the wave generator transmit the wave 5 times and receive the wave 5 times, before making a determination of authentication. The determination can then be based on combined analysis of the received waves. In this manner, the authentication of an individual can be more accurate.

The triggering event can be actuation of the device by an individual. For example, by turning the device on, by releasing a substance from a storage location (reservoir or magazine holding reservoirs) into a use location, and/or by sensing that inhalation through the device has commenced (e.g., sensing a drop in air pressure by a sensor in the device, such as in breath actuated inhalers or by sensing a change in temperature, such as a thermometer being put in a patient's mouth).

The triggering event can be that the substance delivery device 400 has changed its position or moved a distance greater than a predefined minimal range from a location or position where an authorization occurred. For example, an individual, during a single inhalation is typically not supposed to move more than a minimal range of movement typical of inhalation (e.g., unless an inhalation device is passed on to another individual after authentication, which it may be desired to prevent). After the individual is authenticated, if the authentication module 412 determines that the substance delivery device has changed its position significantly (e.g., vertical displacement from a mouth elevation of the authorized individual to a waist elevation, or horizontal displacement, and/or tilting by more than 30 degrees, indicative of passing the inhalation device to another individual) delivery of the substance can stop.

The substance delivery device 400 can include a motion detection sensor (not shown). The motion detection sensor can detect movement of the substance delivery device 400. In some embodiments, the motion detection sensor includes a processor to process waves detected by the sensor and transmit to the processor 434 if the predefined minimal range is exceeded. In some embodiments, the motion detection sensor can be in communication with the processor 434 and the processor 434 can determine if the predefined minimal range is exceeded.

In some embodiments, exceeding the predefined minimal range can cause the substance delivery device 400 to cease delivery of the substance (e.g., by closing the valve 423, shutting off power and/or causing a heating element to cool down) and/or cause the substance delivery device 400 to reset authentication (e.g., behave as if the individual had not been previously authenticated).

The authentication module 412 can be preprogrammed with one or more threshold values defining predefined minimal range. Optionally, once a person is registered and uses a substance delivery device, the threshold values are updated in view of the specific individual's typical motion in use. The authentication may be repeated for each inhalation. This can prevent transfer of the substance delivery device from an authorized individual to one who is not authorized after the first inhalation while allowing the authorized individual to be in ordinary motion during use (e.g. taking a series of inhalations from an e-cigarette).

In some embodiments, the triggering event is inhalation of the individual. In some embodiments, each time inhalation of the individual is sensed, the substance delivery device 400 authenticates the individual.

In some embodiments, the substance delivery device 400 authenticates an individual at least once before delivery and at least once during delivery of the substance. In some embodiments, authentication by the substance delivery device 400 begins before delivery and overlaps a part of delivery.

The predefined minimal range can be an amount of movement that is typical during inhalation/exhalation. The predefined minimal range can be input by an individual. The predetermined number of times can be input by an individual. The predefined period of time can be based on an amount of time that the substance delivery device 400 typically takes to deliver the substance. One or more of the predefined period of time, the predefined minimal range, and the predetermined number of times can be based on substance type.

In various embodiments, when the substance delivery device 400 includes a heating element, the heating element can be prevented from heating above a predefined threshold until authentication is performed. The predefined threshold can be a temperature slightly (e.g., 5-50 deg. C) lower than the substance vaporization temperature, to speed up the delivery time in the event that the individual is authenticated. In some embodiments heating commences only after the individual is authenticated.

In some embodiments, the wave generator 422 may be triggered to transmit waves in a specific manner. For example, wave transmission may be triggered upon initiation of inhalation by a current individual. Such initiation may be supervised, for example by an authorized individual (e.g., a medical doctor or a medical care worker, a seller at a point of sale, verifying authorization for a transaction, a welfare officer, a policeman, a pharmacist, a parent, etc.). Supervision may be most useful for wave transmission during a process of registration.

The substance delivery device 400 can be a medical inhaler, a vaporizer, or an e-cigarette.

Reference is now made to FIG. 5A and 5B, which are schematic diagrams of a substance delivery device 500 (e.g., substance delivery device 400 as described above in FIG. 4) according to some embodiments of the invention.

The substance delivery device 500 includes a housing 510. The housing 510 includes a LED light 512, an airflow aperture 514, a wave sensor aperture 516 and a wave generator aperture 518. During operation, waves exit the wave generator aperture 518, the wave sensor aperture 516 can detect reflection waves, and the airflow aperture 514 can permit a fluid to flow out of the device.

FIG. 5B shows some of the elements housed within the housing 510 of the substance delivery device 500. Electronics and control panel 520, a power unit 522, a wave sensor enclosure 524, an airflow conduit 526, a wave generator enclosure 528, a flexible seal 530 are shown positioned within the housing 510. The electronics and control panel 520 can include any of the elements as described above in FIG. 4. Flexible seal 530 can be made of a flexible material, such as silicon rubber, rubber of other kind, or flexible polymer material. In some embodiments the flexible seal is being in direct contact with the wave generator without having an enclosure therebetween. In some embodiments wave generator enclosure is made of a flexible material, such as silicon rubber or rubber of other kind or flexible polymer material. In some embodiments the wave generator is exposed to the sampled space (e.g., the mouth) via conduit. In some embodiments wave generator is a sound generator, e.g., a speaker, or buzzer and wave sensor is sound wave sensor, e.g., a microphone. In some embodiments, the sound wave sensor can comprise a noise dumper, in order to reduce the recorded background noise and increase the portion of recorded data typical to the individual. In some embodiments, the sound wave sensor is contact microphone, such as a piezoceramic microphone, which can be less sensitive to air vibrations than an air microphone. Each of the wave sensor enclosure 524 and wave generator enclosure 528 can have an open end in the direction of the individual's mouth. The shape of each of enclosures 524, 528 may be tubular, have a conical tube shape, or otherwise cylindrical or irregular. Each of the enclosures 524, 528 can be hollow and have substantially the wave generator or the wave sensor completely enclosed therein. In some embodiments, each of the enclosures 524, 528 may contain a medium, within which the wave generator and/or the wave sensor are disposed.

The wave sensor enclosure 524 houses a wave sensor and has an end that terminates at or near the wave sensor aperture 516. The airflow conduit 526 connected to an interior portion of the substance delivery device 500 that out of which the fluid flows to the individual (e.g., the reservoir 418 as described above in FIG. 4). The wave generator enclosure 528 houses a wave generator (e.g., generator 422 as described above in FIG. 4) and terminates at wave generator cover 530 (e.g., a flexible seal). The flexible seal 530 can cover the wave sensor positioned within the wave generator enclosure 528 to prevent or reduce acoustic interruptions (e.g., noise) caused by friction. In some embodiments, the flexible seal 530 is not present. In some embodiments, the wave generator enclosure 528 and thus the wave sensor is positioned at a distance away from the wave sensor aperture 516 to, for example, prevent or minimize noise. The distance can be determined based on noise level, sensor sensitivity and wave generator power.

In various embodiments, the substance delivery device 500 includes a plurality of wave generators and/or a plurality of wave sensors. The plurality of wave generators can include or be an array of wave generators. The plurality of wave sensors can include or be an array of wave sensors.

In various embodiments, some of the plurality of wave generators or all of the plurality of wave generators are enclosed. In various embodiments, the plurality of wave generators that are enclosed are in a single enclosure or multiple enclosures. In various embodiments, some of the plurality of wave sensors or all of the plurality of wave sensors are enclosed. In various embodiments, the plurality of wave sensors that are enclosed are in a single enclosure or multiple enclosures.

In some embodiments, each enclosure has the same media or different media. In some embodiments, the enclosures have a medium of air.

During operation, in some embodiments, with a plurality of wave generators, the plurality wave generators can be used simultaneous, sequentially or any combination thereof. In some embodiments, the plurality of wave generators transmit the same waves, different waves, or any combination thereof In some embodiments, the plurality of wave sensors receive the same waves, different waves, or any combination thereof

Reference is now made to FIG. 5C and FIG. 5D, FIG. 5C are graphs showing an example of a received wave without a cover on the wave sensor and FIG. 5D are graphs showing an example of the same received waves with a cover on the wave sensor. As shown, the received waves in FIG. 5C have noise that is not present in the received waves in FIG. 5D.

Reference is now made to FIG. 6, which is a flowchart of a method of authenticating an individual for delivery of a substance to the individual, according to some embodiments.

Some embodiments may include transmitting waves (e.g., generated via wave generator 422 as described above in FIG. 4) towards at least a portion of the individual's mouth (610).

Some embodiments may include receiving reflected waves (e.g., via sensor 424 as described above in FIG. 4) that include at least a portion of reflections of the waves from the individual, at least a portion of absorption of the waves by the individual, or both (620). For example, transmitting (610) may be continuous, with receiving (620) being performed intermittently for only a portion of the received waves. In some such embodiments, transmitting may include repeated transmission of the same wave pattern a plurality of times, and optionally, receiving is timed to occur at the same time in each repetition.

Some embodiments may include processing the reflected waves (630). In some embodiments all of the waves received in 620 are used in the processing. In some embodiments, only a portion of the waves received in 620 are used in the processing. For example, transmitting (610) and receiving (620) may be continuous, with processing (630) being performed intermittently for only a portion of the received waves. In some such embodiments, transmitting may include repeated transmission of the same wave pattern a plurality of times, and optionally, processing is performed only for waves that were received at the same time in each repetition.

Processing the reflected waves can involve determining a signature of the individual and/or personal data associated with the individual (e.g., identification of nasal or tympanic cavity). In some embodiments, the processed waves can be analyzed by comparison against stored signatures of individuals who were previously registered and/or or registered as authorized to receive the substance (e.g., registered at a pharmacy database after a physician transmits a prescription to the pharmacy and/or age of date of birth previously verified, identification information stored in a database of individual).

In some embodiments, the reflected waves are analyzed to determine if the individual is a child or adult. In these embodiments, an erroneous determination can be made, namely that an adult is identified by the system as a child (or not identified as an adult) or vice versa—a child is identified as an adult (or is not identified as a child). In such cases, if misidentification prevents use by an individual that should have been authorized (e.g., an adult prevented from smoking tobacco as he is not identified as being an adult) the individual may revert to alternative methods of identification. For example, the individual may be registered on his device in such conditions that allow overriding the child/adult identification, for example, at a point of sale by showing valid identification documentation and proof of age. In such cases the seller can have the authority and/or tools (software, hardware, and/or password) required to enable registration of any individual. In some embodiments, the individual's age and/or authorization and his oral signature are recorded on a mobile device (e.g., a token) that can be used for registration on devices as an override of child/adult identification, for example by way of wireless transfer of information (e.g., Bluetooth, WiFi and/or RFID, etc.) between the mobile device and a controller associated with the device or purpose for which age identification is required. Storing these data and/or the communication can be encrypted to prevent ease of unauthorized override of the age identification.

The wave signature may be obtained in advance in a registration process, in which the authorized individual uses an authentication module (e.g., authentication module 412 of the same device) and data indicative of the wave reflection is saved as a signature for future comparison with obtained wave reflections during use of a device associated with the stored data or having access to the data. During the registration, the wave signature of the individual may be associated with an authorization indication and/or with an identity of the authorized individual and recorded in a memory. In some embodiments, a security token is required during the registration process. In some embodiments, the registration process only occurs once. In various embodiments, the reflected waves can be influenced by one or more features of the current individual's parts of the mouth (e.g., oral cavity, larynx, pharynx, vocal cords, throat, tongue and/or other part of the oral cavity, as well as instantaneous conditions, such as, for example, having something in the mouth, such as a chewing gum, food leftover, retainer, throat lozenge and/or candy). The reflected waves can be influenced by the position of the tongue, or the position and orientation of the fluid delivery device, and in particular the wave generator and/or the wave sensor, the current individual's current activity (e.g. inhalation, exhalation, physical activity, rest, etc.). When used during inhalation, acquired reflections can be associated with specific points of time during the inhalation, which can correlate with changes within the oral cavity that normally occur during use of an inhalation device, and the analysis can take such timing into account. When used during exhalation, acquired reflections can be associated with specific points of time during the exhalation, which can correlate with changes within the oral cavity that normally occur during exhalation, and the analysis can take such timing into account.

In some embodiments, the reflected waves are normalized with respect predetermined reference wave signal of the sound of the environment. In some embodiments, noise is filtered (or substantially filtered), canceled (or substantially cancelled) or any combination thereof from the reflected waves. In some embodiments, the noise is environmental noise. In some embodiments, the portions of the received waves that are below a predefined threshold are filtered out. In some embodiments, the predefined threshold is between −6 and −14 Decibels. In some embodiments, the predefined threshold is between −7 and −12 Decibels and even between −9 and −12. In some embodiments, the predefined threshold is between −6 and −8 Decibels.

Some embodiments may include determining if the individual is an authorized individual (640). In some embodiments the individual is determined to be an authorized based on the processed reflected waves. In some embodiments, additional identification data is used along with the received waves to determine if the individual is an authorized individual. For example, fingerprints, inhalation pattern, voice, retinal scan, breathing pattern, face recognition, and/or any biometric data. The biometric data can include gender, ethnicity, geographical origin, or any combination thereof. In some embodiments, the additional identification information includes historical use of the individual, a password and/or response to one or more security questions. In some embodiments, a likely age of the individual is determined based on the received waves to determine if the individual is authorized. For example, it can be desirable to restrict access of the fluid delivery device to individuals above an age threshold. The determination can, for example, include determining that the individual is above a first threshold and/or that the individual is not below a second threshold. In some embodiments the first threshold and the second threshold are the same. In some embodiments, machine learning algorithms are used for authentication. In some embodiments, machine learning sorting algorithms are used for age determination.

In some embodiments, if the authentication is valid, then some embodiments may include determining if the individual complies with an age limitation based on the analysis of the reflected waves (670). The age limitation can be input by a user, set by a pharmacist, set by a manufacturer, determined based on a type of the device that is used or otherwise set.

If the individual doesn't comply with the age limitation, then Some embodiments may include rejecting the individual (660). If the individual does comply with the age limitation, then Some embodiments may include permitting the individual (680). Each of the authentication of this method may occur more than once during a use event, for example in order to increase the protection and/or prevent passing the device subsequent to authentication to a non-authorized user.

In some embodiments, the method shown in FIG. 6 provides an additional layer of protection, against age related abuse of the device. Accordingly, even if a false identity authorization is issued, the individual is checked again for their age, and an individual who does not meet the age limitation is rejected or stopped.

In some embodiments of an authentication method, a wave reflection data sampled from the mouth of an individual is analyzed compared to a database comprising data of restricted individuals. The individual can be permitted only if they were found non-restricted.

In some embodiments, determining if the individual is a restricted individual is done subsequent to authenticating their identity. In some embodiments, the determination whether an individual is restricted can be additional to the identity authentication. Once an individual is authorized, the system analyses their wave reflection data compared to the restricted individuals' database. If the individual was found non-restricted, they are being permitted.

In some embodiments, the determination whether an individual is restricted can be alternative to the identity authentication. In some embodiments, the system may determine that the identity of an individual is not authenticated. An alternative permission path may be checking whether or not this individual is restricted, and if they were found not restricted, the individual is permitted.

Optionally, a database of restricted and/or permitted users is created by collecting oral signatures of individuals and storing them in association with restriction and/or permission data, respectively. For example, a parent may have their child's oral signature stored on the parent's fluid delivery device as a restricted individual to ensure that the child will not be able to use the parent's device, even if the child is misidentified as an adult. In some embodiments, young adults may opt to register as being of age on a database so that in the event that their oral signatures will not be properly identified by age authentication, they will be identified as permitted individuals via the data base and their presence in the database will override an oral authentication of age. In some embodiments, a young adult may register as such by presenting proof of age at a point of sale.

In some embodiments a device, such as device 400 in FIG. 4, includes a communication unit for retrieving data from a permitted and/or restricted individual database. In some embodiments, a database, or a part thereof (e.g. based on geographic relevance), is stored locally, in the device. In method such as exemplified in FIG. 6, the database may be used to override any other form of authentication.

Reference is now made to FIG. 7A and FIG. 7B, which depict a T-distributed Stochastic Neighbor Embedding (t-SNE) graph, and an enlargement of a portion thereof, visualizing a possible distinction between received waves from eight different individuals, according to some embodiments of an authentication method. The results were collected in an experiment that was conducted in order to test some embodiments of an authentication system.

Reference is now made to FIG. 7C and FIG. 7D, which depict graphs showing a reference wave used in determining the values of wave samples shown in graph of FIG. 7A, according to some embodiments of an authentication method.

Sound wave signal samples were taken from eight (8) different individuals. The individuals were told to insert a probe into their mouth and avoid movement. The probe included a wave generator and a wave sensor, which received the reflected waves. The wave generator was a 46 Ohms Receiver, Balanced Armature Speaker 20 Hz˜8.8 kHz Top Round 105 dB. The wave sensor was a I2S MEMS Microphone, Omnidirectional, −26 dB @ 94 dB SPL.

A chirp of 3200-9200 Hz Linear Frequency Modulated (LFM) sound waves was transmitted into the mouth of the individuals. The chirp included three wave samples, each of which lasted 50 milliseconds with breaks of 50 milliseconds each therebetween. the entire chirp was therefore 250 milliseconds. 20 chirps, hence 60 samples were taken from each of the eight individuals.

A processor recorded the received wave reflections and encoded the received weaves by Digital Signal Processing (DSP) algorithm and stored in a database. A reference chirp of 3200-9200 Hz LFM sound wave samples was transmitted to the surrounding and recorded adjacent to and at the same location of the sampling of the individuals. The chirp included three wave samples, each of which lasted 50 milliseconds with breaks of 50 milliseconds each therebetween. One of the three reference samples is shown in plots 7C and 7D, and represents the ambient sound.

During processing the data, samples were cleaned and normalized with respect to the reference wave. The data was entered to an artificial intelligence (AI) algorithm of the Random Tree kind. The system analyzed the data, compared between the samples and gave each sample a multi-dimensional value that reflects the sample's difference degree with respect to the other samples. The algorithm visualized its analysis using T-distributed Stochastic Neighbor Embedding (t-SNE) on the graph shown in FIG. 7A.

Each of the marks shown on the graph of FIG. 7A represent a single sample. after receiving the result, each sample on the graph was given a symbol with respect to the individual to whom it belongs. For example, the circled symbols represent wave reflections that was received during transmission to the mouth of individual A_0, the square symbols represent wave reflections received from individual A_1, and so forth. As can be seen in FIG. 7A, the AI algorithm arranged the received waves in distinct clusters, each of which comprising samples of the same individual. The results show that the system can distinguish between individuals based on wave reflections received from their mouth. An enlarged portion of FIG. 7A, marked by dashed line 701 is depicted in FIG. 7B to show part of the results at higher resolution. As seen, two clusters 700 of circle symbols represent wave reflections taken from the mouth of individual A_0 and three clusters 710 of inverted triangles represent wave reflections that were taken from the mouth of individual A_5. This two-dimensional representation represents a portion of the data points that were analyzed by the system in this example, and shows that different individuals manifest differently one from the other to a degree significantly greater than the variation between samples taken from the same individual.

Reference is now made to FIGS. 8A and 8B, which depict a T-distributed Stochastic Neighbor Embedding (t-SNE) graph, visualizing a possible distinction between adults and children according to received wave reflections, wherein FIG. 8B is an enlarged portion marked by dashed rectangle 801 of FIG. 8A. The results shown were collected in an experiment that was conducted in order to test some embodiments of an authentication system, and its ability to distinguish between adults and children based on reflections of waves transmitted to their mouth.

Sound wave signal samples were taken from 66 subjects, that included 28 adults and 38 children. Adults were defined by ages above 25. Children were defined by ages of below 15. The subjects were told to insert a probe into their mouth and avoid movement during sampling.

The probe included a sound wave generator and a sensor that received the reflected waves. The wave generator was 46 Ohms Receiver, Balanced Armature Speaker 20 Hz˜8.8 kHz Top Round 105 dB. The wave sensor was I2S MEMS Microphone, Omnidirectional, −26 dB @ 94 dB SPL.

A chirp of 3200-9200 Hz Linear Frequency Modulated (LFM) sound waves was transmitted into the mouth of the individuals. The chirp included three wave samples, each of which lasted 50 milliseconds with breaks of 50 milliseconds each therebetween. the entire chirp was therefore 250 milliseconds. 5 chirps, hence 15 samples were taken from each of the individuals.

A processor recorded the received wave reflections and encoded the received weaves by Digital Signal Processing (DSP) algorithm and stored in a database. A reference wave represents the ambient sound and was recorded adjacent to sampling the mouth of the individual, in a manner similar to recording the reference chirp as detailed in the description of the experiment of FIGS. 7A,7B, 7C and 7D.

During processing the data, samples were cleaned and normalized with respect to the reference wave. As an initial training phase, data relating to 49 of the subjects that were randomly selected was entered to the system. Each of the subject was indicated to the system as an adult/child.

At a next phase, the system analyzed the remaining 17 samples, which were not given an indication. The algorithm was set to determine whether each of the samples belong to an adult or a child. The system analyzed the data, compared between the samples and gave each sample a multi-dimensional value that reflects the sample's difference degree with respect to the other samples. The algorithm visualized its analysis using T-distributed Stochastic Neighbor Embedding (t-SNE) on the graph shown in FIG. 8A.

Each of the marks shown on the graph of FIG. 8A represents a single sample. the algorithm classified each of the samples as an adult or a junior (child). Sample was marked twice. The star was used to mark reflections taken from a junior (child) and a square for an adult. The performance symbols were marked around the classification symbols. A circle marked for a success, i.e., the algorithm classified a child as a child or an adult as an adult. An X shaped symbol marked for failure, i.e., the algorithm classified a child as an adult or an adult as a child. A portion of FIG. 8A shows the region marked by dashed rectangle 801 at higher resolution in FIG. 8B. As seen, 800 marks a sample taken from a junior (star) that was correctly identified as such (circled) and 802 marks a sample taken from an adult (square) that was correctly identified as such (circled). A misidentification by the algorithm is depicted at 804, where an adult (square) was not identified as an adult (marked by an X). In the example shown in FIG. 8A, the model was able to distinguish between a child and an adult with an accuracy of 76.3%. When using a learning algorithm, as the number of samples will increase so the accuracy expected to increase. In addition, by changing the cutoff value, it is possible to decrease the number of false positives at the expense of an increase in false negatives, and vice versa.

As described above, in some embodiments, the determination of an adult or child can be provided by a likelihood of accuracy, for example, the determination of the system can be that a subject is a child by a likelihood of 75%, according to the percentage level (%) of wave trends and properties that are recorded in the system as characterizing a child or an adult.

In some embodiments, a machine learning algorithm can be trained to increase accuracy and efficiency of age and/or other identity criteria recognition. Useful examples of age restriction criteria may be helpful in prevention of tobacco, nicotine, cannabis and/or cannabinoid smoking or vaping by children, as well as prevention of minors or children making use of a medical device.

In some embodiments, a group of people can be allowed to use the same device (e.g., a fluid delivery device such as fluid delivery device 400 as described above in FIG. 4) or a set of devices (e.g., patients' devices in a hospital setting or a few members of the same family). A processor can be configured to allow monitoring of each individual's use. In some embodiments, the same device, based on input from the device can establish a use regime (e.g., substance administration) associated with each authorized individual. In some embodiments the same device may be configured, based on input from the authentication module, to facilitate administration of the same or different substance(s) to a group of authorized individuals, in parallel or at different times and/or dosages. In some embodiments the same device may be used by a group of people, for example by a few members of a family; in a hospital by a few patients.

Aspects of the present invention are described above with reference to flowchart illustrations and/or portion diagrams of methods, apparatus (systems) and computer program products according to embodiments. It will be understood that each portion of the flowchart illustrations and/or portion diagrams, and combinations of portions in the flowchart illustrations and/or portion diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or portion diagram or portions thereof.

These computer program instructions can also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or portion diagram portion or portions thereof. The computer program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or portion diagram portion or portions thereof.

The aforementioned flowchart and diagrams illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments. In this regard, each portion in the flowchart or portion diagrams can represent a module, segment, or portion of code, which includes one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the portion can occur out of the order noted in the figures. For example, two portions shown in succession can, in fact, be executed substantially concurrently, or the portions can sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each portion of the portion diagrams and/or flowchart illustration, and combinations of portions in the portion diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

In the above description, an embodiment is an example or implementation of the invention. The various appearances of “one embodiment”, “an embodiment”, “certain embodiments” or “some embodiments” do not necessarily all refer to the same embodiments. Although various features of the invention can be described in the context of a single embodiment, the features can also be provided separately or in any suitable combination. Conversely, although the invention can be described herein in the context of separate embodiments for clarity, the invention can also be implemented in a single embodiment. Certain embodiments of the invention can include features from different embodiments disclosed above, and certain embodiments can incorporate elements from other embodiments disclosed above. The disclosure of elements of the invention in the context of a specific embodiment is not to be taken as limiting their use in the specific embodiment alone. Furthermore, it is to be understood that the invention can be carried out or practiced in various ways and that the invention can be implemented in certain embodiments other than the ones outlined in the description above.

The invention is not limited to those diagrams or to the corresponding descriptions. For example, flow need not move through each illustrated box or state, or in exactly the same order as illustrated and described. Meanings of technical and scientific terms used herein are to be commonly understood as by one of ordinary skill in the art to which the invention belongs, unless otherwise defined. While the invention has been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention, but rather as exemplifications of some of the preferred embodiments. Other possible variations, modifications, and applications are also within the scope of the invention. Accordingly, the scope of the invention should not be limited by what has thus far been described, but by the appended claims and their legal equivalents. 

1. A system for managing a use of a substance delivery device in a managing zone, the system comprising: at least one system transmitter positioned to transmit a system signal into the managing zone; at least one system receiver positioned to receive a device signal from within the managing zone; and at least one system control unit configured to control the at least one system transmitter to transmit the system signal based on receiving the device signal by the at least one system receiver.
 2. The system of claim 1, comprising a substance delivery device, the substance delivery device having a device transmitter configured to transmit the device signal.
 3. The system of claim 1, wherein at least one of the system signal and the device signal includes at least one of a soundwave and electromagnetic wave. 4-6. (canceled)
 7. A system for managing a use of a substance delivery device in a managing zone, the system comprising: at least one system receiver capable of receiving a device signal transmittable by a substance delivery device; at least one system transmitter; and at least one system control unit configured to control the at least one system transmitter to transmit, into the managing zone, at least one of: a baseline signal; and a managing signal, being transmitted subject to receipt of at least a portion of the device signal by the at least one system receiver. 8-11. (canceled)
 12. The system of claim 7, wherein the at least one system control unit is configured to: control the at least one system transmitter to transmit a release signal; and encode the release signal to comprise a release managing command using a predetermined set of signal encoding parameters; wherein the release managing command causes the substance delivery device to stop performing the function upon receipt of the release signal.
 13. (canceled)
 14. The system of claim 7, wherein the at least one system control unit is configured to: retrieve device-related information from the device signal based on a predetermined set of device-related information encoding parameters; and encode or select the managing signal based on the device-related information.
 15. The system of claim 7, wherein the at least one system control unit is configured to determine a location of the substance delivery device within the managing zone based on at least one of: the device signal and a known location of at least one system receiver that has received the device signal. 16-17. (canceled)
 18. A method of managing a use of a substance delivery device in a managing zone, the method comprising: receiving, by at least one receiver, from within the managing zone, a device signal transmittable by the substance delivery device; and transmitting, by at least one transmitter, into the managing zone, a managing signal upon receipt of at least a portion of the device signal; wherein the managing signal is receivable by the substance delivery device when the substance delivery device is within the managing zone and is capable of causing the substance delivery device to perform a function.
 19. The method of claim 18, further comprising transmitting, by the at least one transmitter, a baseline signal, the baseline signal being receivable by the substance delivery device when the substance delivery device is within the managing zone.
 20. (canceled)
 21. The method of claim 18, comprising encoding, by at least one control unit, at least one of: the managing signal and the baseline signal to comprise at least one managing command using a predetermined set of signal encoding parameters, wherein the at least one managing command defines the function.
 22. The method of claim 18, wherein the function comprises a function selected from the group consisting of at least one of: blocking the substance delivery device for operation, terminating the operation of the substance delivery device, modifying the operation of the substance delivery device, issuing a notification and any combination thereof.
 23. The method of claim 18, wherein at least one of: the baseline signal and the managing signal, comprises a jamming signal, the jamming signal is configured to at least one of: interfere directly with an oral authentication by the substance delivery device; and at least partially overlap with waves used by the substance delivery device for the oral authentication.
 24. The method of claim 18, comprising: transmitting, by the at least one transmitter, a release signal; and encoding, by at least one control unit, the release signal to comprise a release managing command using a predetermined set of signal encoding parameters; wherein the release managing command causes the substance delivery device to stop performing the function upon receipt of the release signal.
 25. The method of claim 18, further comprising: determining, by at least one control unit, whether the substance delivery device is a permitted substance delivery device by retrieving information from a database of registered permitted substance delivery devices; and preventing from the by at least one control unit to interfere with operation of the permitted substance delivery devices. 26-27. (canceled)
 28. The method of claim 18, comprising: defining, by at least one control unit, at least two managing sub-zones within the managing zone; and controlling the at least one transmitter to transmit at least one of: the baseline signal within each of the two managing sub-zones, and at least two managing signals, wherein at least one of the managing signals transmitted in a first managing sub-zone of the at least two managing sub-zones is not transmitted in a second managing sub-zone of the at least two managing sub-zones.
 29. The method of claim 18, comprising: defining, by at least one control unit, at least two managing sub-zones within the managing zone; and controlling the at least one transmitter to transmit at least one of: the baseline signal within each of the at least two managing sub-zones, and at least two release signals, wherein at least one of the release signals transmitted in a first managing sub-zone of the at least two managing sub-zones is not transmitted in a second managing sub-zone of the at least two managing sub-zones.
 30. The system according to claim 2, the substance delivery device further comprising: a reservoir region configured to house a reservoir of a substance within the substance delivery device; a device receiver for receiving a system signal transmittable by the at least one system transmitter in the managing zone; and a device controller for performing a function upon receipt of the system signal by the device receiver. 31-34. (canceled)
 35. The system of claim 30, wherein the device controller is configured to control the device transmitter to transmit the device signal upon at least one of commencement of operation of the substance delivery device, commencement of user authentication by the device, and upon commencement of a substance delivery.
 36. The system claim 30, wherein the device controller is configured to determine the function to be performed based on the system signal received by the device receiver and based on a predetermined set of encoding rules and cause the substance delivery device to perform the function.
 37. (canceled)
 38. The system of claim 30, wherein the function includes preventing the substance delivery device from delivering a substance and wherein preventing the substance delivery device from delivering a substance includes preventing an authentication of an individual. 39-49. (canceled) 